LogoFDA 510(k) Search
K Number
K963326
Device Name
BREATHE FIT
Manufacturer
CAMBRIDGE ASSOC.
Date Cleared
1997-02-12

(173 days)

Product Code
LWF
Regulation Number
874.3900
Type
Traditional
Panel
EN
Reference & Predicate Devices
K192534,K191974
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Not Found

Device Description

Not Found

AI/ML Overview

I apologize, but the provided text "FEB 1 2 1997... Product Name: BREATHE FIT™... Sponsor's Name: Cambridge Associates... SUBSTANTIAL EQUIVALENCE... Breathe Fit™ is substantially equivalent to another commercially available product which uses similar methodology for improving nasal air flow to allow freer breathing. Manufacturer : CNS, Inc. Product: Breathe Right -A drug free, non-prescription adhesive device that mechanically improves nasal breathing by opening the nasal passages." is a 510(k) summary for a nasal dilator and does not contain any information about acceptance criteria, study details, or performance metrics for the BREATHE FIT™ device.

Therefore, I cannot fulfill your request for:

  1. A table of acceptance criteria and reported device performance.
  2. Sample size used for the test set or data provenance.
  3. Number of experts used or their qualifications for ground truth.
  4. Adjudication method for the test set.
  5. MRMC comparative effectiveness study results.
  6. Standalone performance information.
  7. Type of ground truth used.
  8. Sample size for the training set.
  9. How ground truth for the training set was established.

The 510(k) summary primarily focuses on demonstrating substantial equivalence to a predicate device (Breathe Right) based on similar methodology and intended use, rather than providing detailed performance study data. To answer your questions, I would need a significantly more detailed document, such as a full clinical study report, a performance characteristics section of a regulatory submission, or a peer-reviewed publication about the device.

§ 874.3900 Nasal dilator.

(a)
Identification. A nasal dilator is a device intended to provide temporary relief from transient causes of breathing difficulties resulting from structural abnormalities and/or transient causes of nasal congestion associated with reduced nasal airflow. The device decreases airway resistance and increases nasal airflow. The external nasal dilator is constructed from one or more layers of material upon which a spring material is attached, with a skin adhesive applied to adhere to the skin of the nose; it acts with a pulling action to open the nares. The internal nasal dilator is constructed from metal or plastic and is placed inside the nostrils; it acts by pushing the nostrils open or by gently pressing on the columella.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.